Module 18 2021

07/02/2021

Increasing complexity of device components

Credit: Mark Chipperfield, Corvus Device: MedTech and Pharma Platform Zurich 2014

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EEA: Device content of an MAA

 (discussed in principle in the new draft Quality guideline) • 3.2.P should contain information on the product-specific quality aspects related to the device relevant to the quality, safety and efficacy of the medicinal product. • 3.2.R should include relevant information related to the demonstration of compliance of the device(s) with MDR Annex 1 (the GSPRs) e.g. NBOp, NB Certificate of Conformity and/or device manufacturer’s EU Declaration of Conformity. • Module 3 should include appropriate information on the manufacture, control and usability of the DDC as defined for the intended patient population. • Usability and human factor studies are multidisciplinary in nature and could be included in section 5.3.5.4, ‘ Other Clinical Study Reports’ of the CTD, with appropriate reference to Module 3 as these may be reviewed by both pharmaceutical and clinical assessors, each with different focus. • For ATMPs , the content of the MAA may be adapted, provided that this is justified under a risk-based approach.

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